510(k) K954798
- Device
- 7100 SWALLOWING WORKSTATION
- Applicant
- KAY ELEMETRICS CORP.
- 510(k) number
- K954798
- Product code
- KLA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-06-04
- Date received
- 1995-10-18
- Regulation
- 876.1725
- Classification name
- Monitor, Esophageal Motility, And Tube
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM D HARBESON
- Address
- 2 Bridgewater Ln. Lincoln Park NJ US 07035 07035
FDA Registration Numbers#
- 3010170586
- 3012266672
- 2518897
- 3008414621
- 2134626
- 3012159165
- 3017448360
- 9611668
- 1836324
- 3007708502
- 2023374
- 3009445917
- 3006680097
- 2183613
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KLA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242666 | Fecobionics Anorectal System | Gi Bionics, LLC | 2025-02-12 |
| K242304 | RED | Neuraxis, Inc. | 2024-12-06 |
| K234107 | Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | Laborie Medical Technologies, Corp. | 2024-04-23 |
| K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018-03-08 |
| K161785 | THD ANOPRESS | Thd Spa | 2017-03-14 |
| K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | 2015-07-07 |
| K120088 | MCOMPASS ANORECTAL MANOMETRY SYSTEM | Medspira, LLC | 2012-03-29 |
| K062362 | SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS | Sarmed Srl | 2007-04-13 |
| K031617 | MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER | Mediplus , Ltd. | 2004-01-16 |
| K032138 | MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER | Medtronic Vascular | 2003-10-09 |
| K022023 | COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 | Clinical Innovations, Inc. | 2003-01-07 |
| K013704 | MEDIPLUS SINGLE USE GI MANOMETRY CATHETER | Mediplus , Ltd. | 2002-08-05 |
| K983665 | MANOMETRIC ASSEMBLIES | Dentsleeve Pty., Ltd. | 1999-05-17 |
| K964804 | FLEXILOG LS | Oakfield Instruments, Ltd. | 1997-08-06 |
| K964589 | FLEXILOG 3000 | Oakfield Instruments, Ltd. | 1997-03-04 |
Legacy Summary#
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FDA Review#
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